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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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05/29/2024 Sterility 14-599 Complete ISO 14644-9 Second edition 2022-05 Cleanrooms and associated controlled environments - Part 9: Assessment of surface cleanliness for particle concentration
01/30/2014 Sterility 14-427 Complete ISO 13408-1 Second edition 2008-06-15 Aseptic processing of health care products - Part 1: General requirements [Including: Amendment 1 (2013)]
12/18/2023 Sterility 14-593 Complete ASTM F3039-23 Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration
09/17/2018 Sterility 14-516 Complete ASTM F3039-15 Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration
01/27/2015 Sterility 14-456 Complete ANSI AAMI ISO TIR16775:2014 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
ISO TS 16775 First edition 2014-05-15 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
04/04/2016 Sterility 14-277 Complete ANSI AAMI ISO TIR 17665-2:2009 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO ANSI/AAMI/ISO 17665-1
ISO TS 17665-2 First edition 2009-01-15 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1
09/09/2008 Sterility 14-191 Complete ISO 13408-4 First edition 2005-11-01 Aseptic processing of health care products - Part 4: Clean-in-place technologies
ANSI AAMI ISO 13408-4:2005/(R)2014 Aseptic processing of health care products - Part 4: Clean-in-place technologies
09/09/2008 Sterility 14-240 Complete ISO 13408-5 First edition 2006-11-15 Aseptic processing of health care products - Part 5: Sterilization-in-place
ANSI AAMI ISO 13408-5:2006/(R)2015 Aseptic processing of health care products - Part 5: Sterilization in place
08/06/2013 Sterility 14-388 Complete ISO 13408-7 First edition 2012-08-01 Aseptic processing of health care products - Part 7: Alternate processes for medical devices and combination products
ANSI AAMI ISO 13408-7:2012 (R2018) Aseptic processing of health care products - Part 7: Alternate processes for medical devices and combination products
04/04/2016 Sterility 14-333 Complete ISO 17665-1 First edition 2006-08-15 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ANSI AAMI ISO 17665-1:2006/(R)2013 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices
01/27/2015 Sterility 14-166 Complete ISO 14644-7 First edition 2004-10-01 Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
01/30/2014 Sterility 14-430 Complete ISO ASTM 51607 Third edition 2013-06-01 Practice for use of an alanine-EPR dosimery system
09/09/2008 Sterility 14-142 Complete ISO 14698-1:2003 Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 1: General Principles and Methods
06/07/2018 Sterility 14-510 Complete ISO 11137-3 Second edition 2017-06 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control
ANSI AAMI ISO 11137-3:2017/(R)2023 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control
09/09/2008 Sterility 14-239 Complete ISO 13408-3 First edition 2006-09-15 Aseptic processing of health care products - Part 3: Lyophilization
ANSI AAMI ISO 13408-3:2006/(R)2015 Aseptic processing of health care products - Part 3: Lyophilization
09/17/2018 Sterility 14-512 Complete ISO 13408-2 Second edition 2018-01 Aseptic processing of health care products - Part 2: Sterilizing filtration.
ANSI AAMI ISO 13408-2:2018 Aseptic processing of health care products - Part 2:Sterilizing filtration
09/17/2018 Sterility 14-275 Complete ANSI AAMI ST41:2008/(R)2018 Ethylene oxide sterilization in health care facilities: Safety and effectiveness
08/06/2013 Sterility 14-381 Complete ISO ASTM 51261 Second edition 2013-04-15 Practice for calibration of routine dosimetry systems for radiation processing
01/30/2014 Sterility 14-406 Complete ANSI AAMI ST8:2013/(R)2018 Hospital steam sterilizers
04/04/2016 Sterility 14-337 Complete ISO 14937 Second edition 2009-10-15 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ANSI AAMI ISO 14937:2009/(R)2013 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process for medical devices
01/30/2014 Sterility 14-412 Complete AOAC 6.2.01:2013 Official Method 955.14, Testing Disinfectants Against Salmonella choleraesuis, Use-Dilution Method
05/29/2024 Sterility 14-601 Complete ISO 17665 First edition 2024-03 Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
07/09/2014 Sterility 14-432 Complete ANSI AAMI ST58:2013/(R)2018 Chemical sterilization and high-level disinfection in health care facilities
07/09/2014 Sterility 14-435 Complete ASTM F2251-13 (Reapproved 2023) Standard Test Method for Thickness Measurement of Flexible Packaging Material
07/09/2014 Sterility 14-290 Complete ANSI AAMI ST24:1999/(R)2018 Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities, 3ed.
01/30/2014 Sterility 14-402 Complete ASTM F1140/F1140M-13 (Reapproved 2020)e1 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
01/30/2014 Sterility 14-404 Complete ASTM F2250-13 (Reapproved 2018) Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials
01/30/2014 Sterility 14-405 Complete ASTM F2252/F2252M-13 (Reapproved 2018) Standard Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using Tape
08/21/2017 Sterility 14-501 Complete ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
08/21/2017 Sterility 14-502 Complete ISO 11138-1 Third edition 2017-03 Sterilization of health care products - Biological indicators - Part 1: General requirements
ANSI AAMI ISO 11138-1:2017 Sterilization of health care products - Biological indicators - Part 1: General requirements
06/27/2016 Sterility 14-481 Complete ISO 14644-2 Second edition 2015-12-15 Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
06/27/2016 Sterility 14-483 Complete ISO ASTM 52303 First edition 2015-07-15 Guide for absorbed-dose mapping in radiation processing facilities
07/09/2014 Sterility 14-286 Complete ANSI AAMI ST65:2008/(R)2018 Processing of reusable surgical textiles for use in health care facilities
07/06/2020 Sterility 14-543 Complete ISO 11139 First edition 2018-08 Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards
07/06/2020 Sterility 14-544 Complete ISO 18472 Second edition 2018-08 Sterilization of health care products - Biological and chemical indicators - Test equipment
12/23/2016 Sterility 14-500 Complete ISO 14644-1 Second edition 2015-12-15 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration
12/18/2023 Sterility 14-595 Complete ISO 11607-2 Second edition 2019-02 [Including AMD1:2023] Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes [Including Amendment 1 (2023)].
01/30/2014 Sterility 14-403 Complete ASTM F2054/F2054M-13 (Reapproved 2020) Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates
01/27/2015 Sterility 14-165 Complete ISO 14644-5 First edition 2004-08-15 Cleanrooms and associated controlled environments - Part 5: Operations
07/09/2014 Sterility 14-257 Complete ASTM D3078-02 (Reapproved 2021)e1 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
08/06/2013 Sterility 14-383 Complete ISO ASTM 51702 Third edition 2013-04-15 Practice for dosimetry in a gamma facility for radiation processing
05/30/2022 Sterility 14-573 Complete ASTM F88/F88M-21 Standard Test Method for Seal Strength of Flexible Barrier Materials
01/27/2015 Sterility 14-389 Complete ISO 14644-9 First edition 2012-08-15 Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration
01/30/2014 Sterility 14-413 Complete AOAC 6.2.06:2013 Official Method 964.02, Testing Disinfectants Against Pseudomonas aeruginosa, Use-Dilution Method
07/09/2014 Sterility 14-256 Complete ASTM F2095-07 (Reapproved 2021) Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates
05/29/2023 Sterility 14-587 Complete AAMI TIR104:2022 Guidance on transferring health care products between radiation sterilization sources
07/06/2020 Sterility 14-545 Complete ISO ASTM 51276 Fourth edition 2019-08 Practice for use of a polymethylmethacrylate dosimetry system
07/06/2020 Sterility 14-549 Complete ASTM F3004-13 (Reapproved 2020) Standard Test Method for Evaluation of Seal Quality and Integrity Using Airborne Ultrasound
01/15/2013 Sterility 14-213 Complete AOAC 6.2.03:2006 Official Method 991.48, Testing Disinfectants Against Staphylococcus aureus, Hard Surface Carrier Test Method
01/15/2013 Sterility 14-215 Complete AOAC 6.2.05:2006 Official Method 991.49, Testing Disinfectants Against Pseudomonas aeruginosa,Hard Surface Carrier Test Method
01/15/2013 Sterility 14-217 Complete AOAC 6.3.02:2006 Official Method 955.17, Fungicidal Activity of Disinfectants Using Trichophyton mentagrophytes
01/30/2014 Sterility 14-395 Complete ISO 14698-2 First edition 2003-09-15 Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 2: Evaluation and Interpretation of Biocontamination Data [Including: Technical Corrigendum 1 (2004)]
01/30/2014 Sterility 14-397 Complete AOAC 6.2.04:2013 Official Method 955.15, Testing Disinfectants Against Staphylococcus aureus,Use-Dilution Method
01/30/2014 Sterility 14-398 Complete AOAC 6.3.05:2013 Official Method 966.04, Sporicidal Activity of Disinfectants Method I
01/30/2014 Sterility 14-399 Complete AOAC 6.3.06:2012 Official Method 965.12 Tuberculocidal Activity of Disinfectants
01/30/2014 Sterility 14-400 Complete ASTM F2203-13 (Reapproved 2022) Standard Test Method for Linear Measurement Using Precision Steel Rule
12/20/2021 Sterility 14-566 Complete USP-NF M98795_02_01 <55> Biological Indicators -- Resistance Performance Tests
12/20/2021 Sterility 14-567 Complete USP-NF M7414_01_01 <1229.5> Biological Indicators for Sterilization
12/20/2021 Sterility 14-568 Complete USP-NF M98800_01_01 <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
12/20/2021 Sterility 14-569 Complete USP-NF M98810_01_01 <71> Sterility Tests
12/20/2021 Sterility 14-570 Complete USP-NF M98830_02_01 <85> Bacterial Endotoxins Test
05/29/2024 Sterility 14-598 Complete ISO 14644-3 Second edition 2020-06 Cleanrooms and associated controlled environments - Part 3: Test methods
12/21/2020 Sterility 14-554 Complete ASTM F17-20 Standard Terminology Relating to Flexible Barrier Packaging
07/09/2014 Sterility 14-282 Complete ASTM F2338-09 (Reapproved 2020) Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method
01/15/2013 Software/
Informatics		 13-35 Complete ANSI AAMI SW87:2012 Application of quality management system concepts to medical device data systems
12/19/2022 Software/
Informatics		 13-126 Complete ANSI AAMI UL 2800-1-2:2022 Standard for Interoperable Item Development Life Cycle
09/09/2008 Software/
Informatics		 13-9 Complete CLSI AUTO2-A2 Laboratory Automation: Bar Codes for Specimen Container Identification
09/09/2008 Software/
Informatics		 13-10 Complete CLSI AUTO1-A Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard
09/09/2008 Software/
Informatics		 13-12 Complete CLSI AUTO4-A Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard
09/09/2008 Software/
Informatics		 13-13 Complete CLSI AUTO5-A Laboratory Automation: Electromechanical Interfaces; Approved Standard
01/15/2013 Software/
Informatics		 13-36 Complete AAMI TIR 45:2012 Guidance on the use of AGILE practices in the development of medical device software
08/21/2017 Software/
Informatics		 13-88 Complete ISO IEEE 11073-10417 Third edition 2017-04 Health informatics - Personal health device communication - Part 10417: Device specialization - Glucose meter
01/14/2019 Software/
Informatics		 13-106 Complete IEEE Std 11073-10207-2017 Health informatics - Point-of-care medical device communication Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication
01/14/2019 Software/
Informatics		 13-107 Complete ISO 11073-20702 First edition 2018-09 Health informatics - Point-of-care medical device communication - Part 20702: Medical devices communication profile for web services
IEEE Std 11073-20702-2016 Health informatics - Point-of-care medical device communication Part 20702: Medical Devices
03/16/2012 Software/
Informatics		 13-30 Complete CLSI AUTO3-A2 Laboratory Automation: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard
12/23/2016 Software/
Informatics		 13-86 Complete ISO IEC 15026-1 First edition 2013-11-01 Systems and software engineering - Systems and software assurance - Part 1: Concepts and vocabulary
08/21/2017 Software/
Informatics		 13-89 Complete ISO IEEE 11073-10406 First edition 2012-12-01 Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG)
08/14/2015 Software/
Informatics		 13-77 Complete ISO IEC 29147 First edition 2014-02-15 Information technology - Security techniques - Vulnerability disclosure
08/06/2013 Software/
Informatics		 13-59 Complete ISO IEC IEEE 15026-4 First edition 2021-10-01 Systems and software engineering - Systems and software assurance - Part 4: Assurance in the life cycle
12/04/2017 Software/
Informatics		 13-99 Complete ISO IEC 15459-2 Third edition 2015-03-01 Information technology - Automatic identification and data capture techniques - Unique identification - Part 2: Registration procedures
09/09/2008 Software/
Informatics		 13-18 Complete CLSI LIS03-A Standard Guide for Selection of a Clinical Laboratory Information Management System
01/15/2013 Software/
Informatics		 13-34 Complete ANSI AAMI IEC TIR80002-1:2009 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
IEC TR 80002-1 Edition 1.0 2009-09 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
12/23/2016 Software/
Informatics		 13-87 Complete ISO IEC 15026-2 First edition 2011-02-15 Systems and software engineering - Systems and software assurance - Part 2: Assurance case
09/09/2008 Software/
Informatics		 13-19 Complete CLSI LIS04-A Standard Guide for Documentation of Clinical Laboratory Computer Systems
09/09/2008 Software/
Informatics		 13-20 Complete CLSI LIS05-A Standand Specification for Transferring Clinical Observations Between Independent Computer Systems
09/09/2008 Software/
Informatics		 13-21 Complete CLSI LIS06-A Standard Practice for Reporting Reliability of Clinical Laboratory Information Systems
09/09/2008 Software/
Informatics		 13-22 Complete CLSI LIS07-A Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory
09/09/2008 Software/
Informatics		 13-23 Complete CLSI LIS08-A Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems
09/09/2008 Software/
Informatics		 13-24 Complete CLSI LIS09-A Standard Guide for Coordination of Clinical Laboratory Services within the Electronic Health Record Environment and Networked Architectures
08/21/2017 Software/
Informatics		 13-93 Complete IEEE Std 11073-10422-2016 Health informatics - Personal health device communication, Part 10422: Device Specialization - Urine Analyzer
12/04/2017 Software/
Informatics		 13-101 Complete ISO IEC 15459-6 Second edition 2014 Corrected 2016 Information technology - Automatic identification and data capture techniques - Unique identification - Part 6: Groupings
08/14/2015 Software/
Informatics		 13-75 Complete ISO IEEE 11073-10102 First edition 2014-03-01 Health informatics - Point-of-care medical device communication - Part 10102: Nomenclature - Annotated ECG
08/14/2015 Software/
Informatics		 13-78 Complete INCITS ISO IEC 30111 First edition 2013-11-01 (R2019) Information technology - Security techniques - Vulnerability handling processes
08/06/2013 Software/
Informatics		 13-37 Complete CLSI AUTO7-A Laboratory Automation: Data Content for Specimen Identification; Approved Standard
01/30/2014 Software/
Informatics		 13-63 Complete ANSI AAMI IEC TIR 80001-2-4:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-4: General implementation guidance for healthcare delivery organizations
IEC TR 80001-2-4 Edition 1.0 2012-11 Application of risk management for IT-networks incorporating medical devices -- Part 2-4: Application guidance - General implementation guidance for healthcare delivery organization
08/21/2017 Software/
Informatics		 13-97 Complete IEC 82304-1 Edition 1.0 2016-10 Health software - Part 1: General requirements for product safety
07/09/2014 Software/
Informatics		 13-65 Complete UL ANSI 1998 Third Edition 2013 Standards for Safety Software in Programmable Components, Second Edition. [This Standard contains revisions through and including October 28, 2008]
05/29/2024 Software/
Informatics		 13-137 Complete IEEE Std 11073-10101b-2023 Health informatics - Point-of-care medical device communication. Part 10101: Nomenclature
08/06/2013 Software/
Informatics		 13-38 Complete IEC 80001-1 Edition 1.0 2010-10 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
ANSI AAMI IEC 80001-1:2010 Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities
08/14/2015 Software/
Informatics		 13-76 Complete ISO 11073-91064 First edition 2009-05-01 Health informatics - Standard communication protocol - Computer-assisted electrocardiography
 
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